Open Access(Bio)manufactured Solutions for Treatment of Bone Defects with an Emphasis on US‐FDA Regulatory Science Perspective
Author(s) -
Ghelich Pejman,
Kazemzadeh-Narbat Mehdi,
Hassani Najafabadi Alireza,
Samandari Mohamadmahdi,
Memić Adnan,
Tamayol Ali
Publication year - 2022
Publication title -
advanced nanobiomed research
Language(s) - English
Resource type - Journals
ISSN - 2699-9307
DOI - 10.1002/anbr.202100073
Subject(s) - food and drug administration , engineering ethics , perspective (graphical) , risk analysis (engineering) , medicine , engineering , computer science , artificial intelligence
Bone defects, with second highest demand for surgeries around the globe, may lead to serious health issues and negatively influence patient lives. The advances in biomedical engineering and sciences have led to the development of several creative solutions for bone defect treatment. This review provides a brief summary of bone graft materials, an organized overview of top‐down and bottom‐up (bio)manufacturing approaches, plus a critical comparison between advantages and limitations of each method. Additive manufacturing techniques and their operation mechanisms in detail are specifically discussed. Next, the hybrid methods and promising future directions for bone grafting are reviewed while giving a comprehensive United States Food and Drug Administration (US‐FDA) regulatory science perspective, biocompatibility concepts and assessments, and clinical considerations to translate a technology from a research laboratory to the market. The topics covered in this review can potentially fuel future research efforts in bone tissue engineering, and perhaps can also provide novel insights for other tissue engineering applications.